GxP Sr. Consultant / Subject Matter Expert - Life Sciences

Pharmavise Corporation; United States; Remote; USD 120,000 - 160,000; Part time

Job summary

A consulting firm specializing in GxP is seeking a Mid-Senior level consultant for a remote position. This role involves leading consulting engagements, optimizing Quality Management Systems, and guiding compliance for pharma and biotech clients. The ideal candidate should have over 15 years of experience in GxP environments and expertise in regulatory affairs and quality assurance. This contract-based role offers flexibility with full-time and part-time options based on project needs.

Qualifications

• 15+ years of experience in GxP environments within pharma or biotech.
• Expertise in Quality Assurance or Regulatory Affairs.
• Strong knowledge of global GxP regulations.

Responsibilities

• Lead GxP-focused consulting engagements across various functions.
• Develop and optimize Quality Management Systems and regulatory frameworks.
• Provide guidance on compliance readiness and regulatory inspections.

Skills

GxP expertise

Quality Management Systems

Regulatory Compliance

Consulting Skills

Project Leadership

Communication Skills

Education

Advanced degree in Life Sciences or related field

Job description

This is a remote position.

Key Responsibilities

• Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.
• Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.).
• Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations).
• Design, execute, and oversee validation and qualification programs:
  • Process validation
  • Equipment qualification (IQ/OQ/PQ)
  • Software/CSV (21 CFR Part 11)
  • Cleaning and sterilization validation
  • Computerized systems validation
• Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements.
• Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks.
• Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management.
• Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables.
• Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training.
• Support change management, technology transfer, and scale-up initiatives for manufacturing and operations.
• Travel to client sites as needed for assessments, workshops, audits, and project execution.

Required Qualifications

• 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
• Recognized subject matter expertise in at least one of the following domains:
  • Quality Assurance / Quality Systems
  • Regulatory Affairs
  • Validation & Engineering (Process, Equipment, Automation, CSV)
  • Manufacturing Operations / Tech Transfer
  • Clinical Operations & Compliance
  • Risk Management (ISO 14971)
  • Design Controls (21 CFR 820, ISO 13485)
• Strong working knowledge of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.).
• Proven ability to lead cross‑functional projects and serve as a senior advisor for complex technical challenges.
• Prior experience in consulting, advisory, or client-facing technical leadership roles.
• Excellent communication, documentation, and presentation skills.

Preferred Qualifications

• Advanced degree in Life Sciences, Engineering, Quality, Regulatory, or related field.
• Previous work with both large multinational organizations and small/emerging companies.
• Experience navigating regulatory submissions (510(k), PMA, NDA, BLA, IND, Technical Files).
• Professional certifications such as:
  • ASQ (CQE, CQA, CMQ/OE)
  • RAC (Regulatory Affairs Certification)
  • PMP
  • Six Sigma Green/Black Belt

Engagement Type

This is a consulting/contract-based role. Engagements vary by project and may include:

• Full‑time project support
• Part‑time advisory
• Fixed deliverable‑based engagements
• Remote, hybrid, or on‑site work depending on client needs

Please note: We are currently building our database for GxP Consultants. Once we have active requisitions that align with your expertise, we will reach out to discuss potential opportunities.

Additional Information

• Seniority level: Mid‑Senior level
• Employment type: Contract
• Job function: Consulting
• Industries: Business Consulting and Services